前立腺肥大症に対するアルファ遮断剤(塩酸ブナゾシン)の臨床効果

Abstract

55～83歳の前立腺肥大症患者35例において, 本剤1.5 mg/日投与群と3.0 mg/日投与群とを比較したが, 主治医による自覚症状改善度, 他覚所見改善度, 全般改善度, 概括安全度, 有用度の判定, 並びに判定委員会による薬剤効果の判定において, 両群間に統計学的有意差が認められず, 初回投与量は1.5 mg/日が至適と考えられた.12週間投与した症例で特徴的な副作用はなかった.主治医判定における12週後の改善度は, 4週後の改善度に比べ低かった.しかし判定委員会判定で自覚症状の重症度及び他覚所見は, 12週後では4週に比べ, より改善が認められた

Thirty-five patients with prostatic hyperplasia were entered into a randomized controlled study using bunazosin hydrochloride(alpha 1-adrenergic blocker). Eighteen patients were allocated to be treated with an initial dose of 1.5 mg/day (group 1) and 17 patients received an initial dose of 3.0 mg/day (group 2). Subjective symptoms and parameters of urodynamic studies were evaluated after 4 weeks and 12 weeks. There were 5 withdrawals or exclusions within 4 weeks and 6 within 12 weeks. Therefore, 15 patients in group 1 and 15 patients in group 2 were eligible for evaluation at 4 weeks, 12 patients in group 1 and 11 patients in group 2 were eligible for evaluation at 12 weeks. The rates of the improvement in subjective symptoms such as retarded urination, protracted urination, weakened urinary stream, abdominal straining on voiding, and sense of residual urine were 40%, 25% in group 1 and 46.7%, 36.4% in group 2, at 4 weeks and at 12 weeks, respectively. The rate of improvement in objective parameters of the urodynamic study such as voiding volume, residual volume, maximum flow rate and average flow rate were 26.7%, 16.7% in group 1 and 26.7%, 20.0% in group 2, at 4 weeks and at 12 weeks, respectively. Thus, these improvements were not correlated with the dosage of drug. Adverse effects such as diarrhea, mild headache, palpitation and gastric disturbance were observed in 2 patients in group 1, and 3 patients in group 2. In the 24 patients treated with the drug over 12 weeks, there were no specific adverse effects due to prolonged administration. These findings showed that bunazosin hydrochloride is beneficial for the treatment of prostatic hyperplasia, and could be safety administered for a prolonged period of time up to 12 weeks.